Roche Submits Ocrelizumab (OCREVUS) Marketing Application in China for Relapsing and Primary Progressive Multiple Sclerosis

On July 28, the CDE website showed that the marketing application of Roche's Ocrelizumab (Ocrelizumab, OCREVUS) has been accepted, with the speculated indication for the treatment of relapsing or primary progressive multiple sclerosis.

Ocrelizumab is a humanized monoclonal antibody targeting CD20-positive B cells, a specific type of immune cell considered a key factor in causing damage to myelin and neuronal axons. Ocrelizumab is the first and only therapy approved for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), with more than 300,000 patients treated worldwide.

In 2017, Ocrelizumab was approved in the United States and became a blockbuster drug in its second year on the market. In 2021, Ocrelizumab sales reached 5.055 billion Swiss francs, claiming the title of Roche's best-selling drug. In 2022, the drug’s sales maintained double-digit rapid growth, firmly securing its position as Roche's top product.

Multiple Sclerosis (MS) is a chronic autoimmune disease with over 2.8 million patients worldwide. In MS, the immune system erroneously attacks the myelin sheath of nerve cells in the central nervous system, causing inflammation and damage that may lead to a range of symptoms, including muscle weakness, fatigue, and vision difficulties, potentially resulting in disability. The majority of MS patients experience their first symptoms between the ages of 20 and 40, making the disease a leading cause of non-traumatic disability among young adults.

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